01 1NORDIC SYNTHESIS AB
01 1TACRINE HYDROCHLORIDE MONOHYDRATE
01 1Sweden
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10962
Submission : 1994-06-21
Status : Inactive
Type : II
A Tacrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tacrine, including repackagers and relabelers. The FDA regulates Tacrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tacrine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Tacrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tacrine supplier is an individual or a company that provides Tacrine active pharmaceutical ingredient (API) or Tacrine finished formulations upon request. The Tacrine suppliers may include Tacrine API manufacturers, exporters, distributors and traders.
click here to find a list of Tacrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tacrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Tacrine active pharmaceutical ingredient (API) in detail. Different forms of Tacrine DMFs exist exist since differing nations have different regulations, such as Tacrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tacrine DMF submitted to regulatory agencies in the US is known as a USDMF. Tacrine USDMF includes data on Tacrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tacrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tacrine suppliers with USDMF on PharmaCompass.
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